Skip to main content

Built for ANZ medical device manufacturers, distributors and service providers.

WHS / HSWA compliance, ISO 45001 + ISO 9001 alignment and an evidence trail that satisfies internal audit and TGA / Medsafe expectations on a shared footing.

What medical devices teams use most.

Six modules that solve the work in front of you. The rest of the platform is one click away.

Professional+

Training records

Course catalogue, sessions, attendees and competency sign-off.

  • CSV import for legacy records
  • Smart enrolment by competency gap (Business)
  • Recommended training plan suggestions

Documents drafted most by medical devices teams

  • WHSMS Gap Analysis
  • Internal Audit Programme
  • NCR / CAPA
  • Management Review
  • Officer Verification Report

The work that keeps your safety lead up at night.

You hold ISO 13485 for the product but your WHSMS sits in a 12-year-old PDF.

How RAE IQ answers

Upload your WHSMS, get an Opus-level clause-by-clause gap report against ISO 45001 and the WHS Acts. Regenerate weak sections in place.

Your QMS audit programme runs like clockwork. Your safety audit programme is two Post-its.

How RAE IQ answers

ISO 9.2-aligned internal audit programme: schedule, AI-drafted checklists per process area, finding capture, CAPA linkage, audit report PDFs.

Officer due diligence is a board agenda item with no evidence behind it.

How RAE IQ answers

Quarterly attestation workflow, dd-actions register, board-grade Officer Verification Report covering all six s27 / s44 limbs.

Stop writing safety documents from scratch.

Join Australian businesses running their compliance on RAE IQ. 3 free documents, no credit card. The free tier covers a typical week for a sole trader.